1. Field of the Invention
The present invention relates generally to the fields of fluid collection devices, especially devices for the collection of viscous samples, such as saliva, and methods of use thereof. The collection device of the present invention can be used in conjunction with a test device for detecting an analyte of interest, such as an analyte relating to drug abuse, a disease state, medical condition or etiological agent, in the collected fluid.
2. Description of the Related Art
There are a variety of clinical lateral flow immunoassay devices useful for testing for the presence of an analyte, such as hormones, sugar, adulterants, drugs of abuse and the like, in a sample. In general, these test devices take the form of urine cups with accompanying test cards, dip sticks and cassettes. All of these devices require the use of a potentially infective biological fluid, such as urine, blood or serum that clinical workers find messy and offensive to work with and potentially expose the worker to disease. For example, urine cups are often urinated on the exterior and are easily spilt. Similarly, blood samples require the use of needles for collection, which can expose the clinical worker to a variety of blood-born diseases, such as AIDS and hepatitis.
An additional problem with tests that use urine is that urine can be contaminated with other substances. This is a constant problem in drug of abuse testing setting. Subjects using illegal drugs often attempt to hide the presence of those drugs in their urine, in order to have a negative test. These people do this by adding contaminating substances, such as bleach or ammonia, to the urine sample before giving the sample to the clinical worker. Using saliva as a sample fluid eliminates the contamination problem because the subject is never alone while producing the sample, thus eliminating an opportunity to contaminate the sample.
While the afore mentioned devices have been improving, there continues to be a long felt need for a device that is simple to use, not messy and poses little health risk to the clinical worker. This long felt need is met by the present invention, which is described in detail herein. The present invention contemplates the collection, storage and use of a subject's saliva, which is not classified as a biohazard, by simple, easy, clean and noninvasive methods.